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Copper-bearing IUDs (Cu-IUD) and levonorgestrel-releasing

6. Summary of changes within the Selected practice recommendations for

7.2 Intrauterine devices

7.2.1 Copper-bearing IUDs (Cu-IUD) and levonorgestrel-releasing

Initiation of Cu-IUD

Having menstrual cycles

• Within 12 days after the start of menstrual bleeding: A Cu-IUD can be inserted at the woman’s convenience, not just during menstruation. No additional contraceptive protection is needed.

• More than 12 days since the start of menstrual bleeding: A Cu-IUD can be inserted at the woman’s convenience if it is reasonably certain that she is not pregnant.

No additional contraceptive protection is needed.

Amenorrhoeic (non-postpartum)

• A Cu-IUD can be inserted at any time if it can be determined that the woman is not

7. Recommendations 27

pregnant. No additional contraceptive protection is needed.

Postpartum (breastfeeding and non-breastfeeding, including post-caesarean section)

• Within 48 hours after delivery: A Cu-IUD can be inserted, including immediately after delivery of the placenta.

− If the delivery is by caesarean section, the Cu-IUD can be placed after delivery of the placenta, before closing the uterus.

• 48 hours to less than 4 weeks postpartum:

Use of Cu-IUDs is not usually recommended unless other more appropriate methods are not available or not acceptable (MEC category 3).

• 4 or more weeks postpartum and amenorrhoeic:

− Breastfeeding: A Cu-IUD can be inserted if it is reasonably certain that the woman is not pregnant. No additional contraceptive protection is needed.

− Non-breastfeeding: A Cu-IUD can be inserted if it can be determined that the woman is not pregnant. No additional contraceptive protection is needed.

• 4 or more weeks postpartum and menstrual cycles have returned: A Cu-IUD can be inserted as advised for other women having menstrual cycles.

• Women who have puerperal sepsis should not have a Cu-IUD inserted (MEC category 4).

Post-abortion

• A Cu-IUD can be inserted immediately after a first-trimester abortion.

• A Cu-IUD can generally be inserted immediately after a second-trimester abortion.

• A Cu-IUD should not be inserted

immediately following septic abortion (MEC category 4).

Switching from another method

• A Cu-IUD can be inserted immediately if

For emergency contraception

• A Cu-IUD can be inserted within 5 days of unprotected intercourse as an emergency contraceptive.

• In addition, when the time of ovulation can be estimated, a Cu-IUD can be inserted beyond 5 days after intercourse, as long as insertion does not occur more than 5 days after ovulation.

• Women who use the Cu-IUD for emergency contraception should be medically eligible for the insertion (1).

Initiation of LNG-IUD

Having menstrual cycles

• Within 7 days after the start of menstrual bleeding: An LNG-IUD can be inserted at the woman’s convenience, not just during menstruation. No additional contraceptive protection is needed.

• More than 7 days since the start of menstrual bleeding: An LNG-IUD can be inserted at the woman’s convenience if it is reasonably certain she is not pregnant. She will need to abstain from sex or use additional contraceptive protection for the next 7 days.

Amenorrhoeic (non-postpartum)

• An LNG-IUD can be inserted at any time if it can be determined that the woman is not pregnant. She will need to abstain from sex or use additional contraceptive protection for the next 7 days.

Postpartum (breastfeeding and non-breastfeeding, including post-caesarean section)

• Within 48 hours after delivery: An LNG-IUD can generally be inserted, including immediately after the delivery of the placenta.

− If the delivery is by caesarean section, the LNG-IUD can be placed after delivery of the placenta, before closing the uterus.

• 48 hours to less than 4 weeks

• 4 or more weeks postpartum and amenorrhoeic:

− Breastfeeding: An LNG-IUD can be inserted if it is reasonably certain that the woman is not pregnant. No additional contraception is needed.

− Non-breastfeeding: An LNG-IUD can be inserted if it can be determined that the woman is not pregnant. No additional contraceptive protection is needed.

• 4 or more weeks postpartum and menstrual cycles have returned: An LNG-IUD can be inserted as advised for other women having menstrual cycles.

• Women who have puerperal sepsis should not have an LNG-IUD inserted (MEC category 4).

Post-abortion

• An LNG-IUD can be inserted immediately after a first-trimester abortion.

• An LNG-IUD can generally be inserted immediately after a second-trimester abortion.

• An LNG-IUD should not be inserted

immediately following septic abortion (MEC category 4).

Switching from another method

• If a woman is having menstrual cycles, an LNG-IUD can be inserted immediately if it is reasonably certain the woman is not pregnant; there is no need to wait until her next menstrual period. If the woman is amenorrhoeic, an LNG-IUD can be inserted immediately if it can be determined that she is not pregnant; there is no need to wait for her next menstrual period.

− Within 7 days after the start of menstrual bleeding: An LNG-IUD can be inserted.

No additional contraceptive protection is needed.

− More than 7 days since the start of menstrual bleeding: An LNG-IUD can be inserted. She will need to abstain from sex or use additional contraceptive protection for the next 7 days.

• If the woman’s previous method was an injectable contraceptive, the LNG-IUD should be inserted when the repeat injection

would have been given. No additional contraceptive protection is needed.

Remarks (See references 2–4)

The Guideline Development Group (GDG) determined that there is an acceptably low risk of ovulation up to day 7 of the menstrual cycle and that the probability of an existing pregnancy is therefore low before day 8.

The recommendations of the GDG for insertion of Cu-IUDs for the purposes of emergency contraception do not apply to LNG-IUDs because the safety and effectiveness of LNG-IUD use for emergency contraception is unknown. Thus, the use of the LNG-IUD as an emergency contraceptive is not recommended.

Further, there are theoretical concerns that in the event of pregnancy there may be added risks to the fetus due to hormonal exposure.

Whether there is an increased risk of fetal abnormalities due to this exposure, however, is unknown.

As stated in the MEC, the IUD is not indicated during pregnancy and should not be used because of the risk of serious pelvic infection and septic spontaneous abortion. The GDG recognized that the checklist of six criteria will be helpful to the provider in determining whether a woman who is postpartum and breastfeeding may be pregnant (see section 7.1:

How can a health-care provider be reasonably certain that a woman is not pregnant?).

However, for a woman who is postpartum and non-breastfeeding, or one who is amenorrhoeic (non-postpartum), these six criteria do not apply and other means should be used to determine whether she is pregnant.

Examinations and tests before providing Cu-IUD or LNG-IUD (5, 6)

In healthy women, the only examinations and tests that are essential and mandatory before IUD insertion include a pelvic/genital examination and STI risk assessment. When available, a haemoglobin test and STI/HIV screening will also contribute substantially to safe and effective use. Please see the table and notes below for further information.

7. Recommendations 29

Examination or test Cu-IUD and LNG-IUD*

Breast examination by provider C

Pelvic/genital examination A

Cervical cancer screening C

Routine laboratory tests C

Haemoglobin test B

STI risk assessment: medical history and

physical examination A‡

STI/HIV screening: laboratory tests B‡

Blood pressure screening C

* Class A: The examination or test is essential and mandatory in all circumstances for safe and effective use of the contraceptive method;

Class B: The examination or test contributes substantially to safe and effective use, but implementation may be considered within the public health and/or service context. The risk of not performing the examination or test should be balanced against the benefits of making the contraceptive method available; Class C: The examination or test does not contribute substantially to safe and effective use of the contraceptive method.

‡ The Medical eligibility criteria for contraceptive use, fifth edition, states: “IUD insertion may further increase the risk of PID [pelvic inflammatory disease] among women at increased risk of STIs, although limited evidence suggests that this risk is low. Current algorithms for determining increased risk of STIs have poor predictive value. Risk of STIs varies by individual behaviour and local STI prevalence. Therefore, while many women at increased risk of STIs can generally have an IUD inserted, some women at increased risk (very high individual likelihood) of STIs should generally not have an IUD inserted until appropriate testing and treatment occur” (1).

Use of prophylactic antibiotics at the time of IUD insertion

Routine IUD insertion (Cu-IUD or LNG-IUD)

• Prophylactic antibiotics are generally not recommended for IUD insertion. In settings of both high prevalence of cervical gonococcal and chlamydial infections and limited STI screening, such prophylaxis may be considered.

• The IUD user should be counselled to watch for symptoms of pelvic inflammatory disease (PID), especially during the first month of use.

Remarks (See reference 7)

The GDG determined that prophylactic

antibiotics for IUD insertion provide little, if any, benefit for women at low risk for STIs.

These recommendations apply to healthy women; women with health conditions that

As no evidence was identified for the provision of prophylactic antibiotics prior to insertion of the LNG-IUD, these recommendations were based on evidence for the Cu-IUD.

Management of menstrual abnormalities for Cu-IUD users

Spotting or light bleeding

• Spotting or light bleeding is common during the first 3–6 months of Cu-IUD use. It is not harmful and usually decreases over time.

• If a woman desires treatment, a short course of nonsteroidal anti-inflammatory drugs (NSAIDs) may be given during the days of bleeding.

• In women with persistent spotting and bleeding, gynaecologic problems should be excluded when clinically warranted. If a gynaecologic problem is identified, treat the condition or refer the woman for care.

• If no gynaecologic problems are found, and the woman finds the bleeding unacceptable, remove the IUD and help her choose

another method.

Heavier or longer menstrual bleeding than with normal menstrual periods

• Heavier or longer menstrual bleeding is common during the first 3–6 months of Cu-IUD use. Usually this is not harmful, and bleeding typically becomes lighter over time.

• The following treatment may be offered during the days of menstrual bleeding:

− NSAIDs

− tranexamic acid (a haemostatic agent)

• Aspirin should NOT be used.

• Gynaecologic problems should be excluded when clinically warranted. If a gynaecologic problem is identified, treat the condition or refer the woman for care.

• If the bleeding continues to be very heavy or prolonged, especially if there are clinical signs of anaemia, or if the woman finds the bleeding unacceptable, remove the IUD and

Remarks (See reference 8)

The GDG noted that menstrual abnormalities are common in the first 3–6 months of IUD use and concluded that treatment during the days of bleeding can sometimes be effective.

The GDG indicated that aspirin should not be used to treat IUD-related menstrual bleeding because it may worsen the problem.

Management of menstrual abnormalities for LNG-IUD users

Amenorrhoea

• Amenorrhoea does not require any medical treatment. Counselling is sufficient.

• If a woman finds amenorrhoea

unacceptable, remove the LNG-IUD and help her choose another method.

Spotting or light bleeding

• Spotting or light bleeding is common with LNG-IUD use. It is not harmful and usually decreases over time.

• In women with persistent spotting and bleeding, gynaecologic problems should be excluded when clinically warranted. If a gynaecologic problem is identified, treat the condition or refer the woman for care.

• If no gynaecologic problems are found and the woman finds the bleeding unacceptable, remove the LNG-IUD and help her choose another method.

Heavier or longer menstrual bleeding than with normal menstrual periods

• Heavier or longer menstrual bleeding may occur during the first 3–6 months of LNG-IUD use. Usually this is not harmful, and bleeding typically becomes lighter over time.

• Gynaecologic problems should be excluded when clinically warranted. If a gynaecologic problem is identified, treat the condition or refer the woman for care.

• If the bleeding continues to be very heavy or prolonged, especially if there are clinical signs of anaemia, or if the woman finds the bleeding unacceptable, remove the LNG-IUD and help her choose another method.

• To prevent anaemia, provide an iron supplement and/or encourage her to eat foods containing iron.

Remarks

The GDG noted that the risk of heavier or longer menstrual bleeding is concentrated in the first 3–6 months of LNG-IUD use and decreases over time. No studies were available that assessed treatment alternatives.

Management of IUDs when a Cu-IUD or LNG-IUD user is found to have pelvic inflammatory disease (PID)

• Treat the PID using appropriate antibiotics.

• There is no need to remove the IUD if the woman wishes to continue its use.

• If she does not want to keep the IUD, remove it after antibiotic treatment has been started.

• If the IUD is removed, consider using emergency contraceptive pills and/or other contraceptive method(s), if appropriate.

• If the infection does not improve, consider removing the IUD while continuing antibiotics. If the IUD is not removed, antibiotics should still be continued. In both circumstances, the woman’s health should be closely monitored.

• Provide comprehensive management for STIs, including counselling about condom use.

Remarks (See reference 9)

The GDG concluded that removing the IUD provides no additional benefit once PID is being treated with appropriate antibiotics. As no evidence was identified for the LNG-IUD, the recommendations were based solely upon evidence for the Cu-IUD.

Management of the IUD when a Cu-IUD or LNG-IUD user is found to be pregnant

• Exclude ectopic pregnancy.

• Explain to the woman that she is at an increased risk of first- and second-trimester miscarriage (including septic miscarriage that may be life-threatening) and of preterm delivery if the IUD is left in place.

The removal of the IUD reduces these risks, although the procedure itself entails a small risk of miscarriage.

− If she does not want to continue the pregnancy and if therapeutic termination of pregnancy is legally available, inform her accordingly.

7. Recommendations 31

− If she understands and accepts the risks mentioned above and she wishes to continue the pregnancy, proceed according to the instructions below.

The IUD strings are visible or the IUD can be retrieved safely from the cervical canal

• Advise the woman that it is best to remove the IUD.

• If the IUD is to be removed, remove it by pulling on the strings gently.

• Whether the IUD is removed or kept, advise her to seek care promptly if she has heavy bleeding, cramping, pain, abnormal vaginal discharge or fever.

The IUD strings are not visible and the IUD cannot be safely retrieved

• Where ultrasound is available, it may be useful in determining the location of the IUD. If the IUD is not located, this may suggest that expulsion or perforation of the IUD has occurred.

• If ultrasound is not possible or if the IUD is determined by ultrasound to be inside the uterus, make the risks of miscarriage, infection and preterm delivery clear to the woman and advise her to seek care promptly if she has heavy bleeding, cramping, pain, abnormal vaginal discharge or fever.

Remarks (See reference 10)

The GDG concluded that removing the IUD improves pregnancy outcome if the IUD strings are visible or can be retrieved safely from the cervical canal, and that the risks of miscarriage, preterm delivery and infection are substantial if the IUD is left in place. These recommendations were based on evidence for the Cu-IUD. In addition, the GDG considered that there are theoretical concerns about fetal exposure to hormones in women found to be pregnant with an LNG-IUD in place. Whether there is an increased risk of fetal abnormalities due to this exposure, however, is unknown.

Appropriate follow-up after insertion of a Cu-IUD or LNG-IUD

These recommendations address the minimum frequency of follow-up recommended for safe and effective use of IUDs. They refer to general situations and may vary for different users and different contexts. For example, women with specific medical conditions may need more frequent follow-up visits.

• A follow-up visit is recommended after the first menses or 3–6 weeks following insertion.

• Women should be advised to return at any time to discuss side-effects or other problems, or if they want to change methods.

• Women should be advised to return when it is time for IUD removal.

Remarks (See reference 11)

The GDG concluded that follow-up visits or contacts should include, at a minimum, counselling to address issues such as side-effects or other problems, correct and consistent use of the method, and protection against STIs. Additional assessment may be appropriate, e.g. pelvic examination to check for IUD displacement.

References for intrauterine devices (IUDs)

1. Medical eligibility criteria for contraceptive use, fifth edition.

Geneva: World Health Organization; 2015 (http://www.

who.int/reproductivehealth/publications/family_planning/

MEC-5/en/, accessed 8 July 2016).

2. Whiteman MK, Tyler CP, Folger SG, Gaffield ME, Curtis KM.

When can a woman have an intrauterine device inserted?

A systematic review. Contraception. 2013;87(5):666–73.

doi:10.1016/j.contraception.2012.08.015.

3. Wilcox AJ, Dunson D, Baird DD. The timing of the “fertile window” in the menstrual cycle: day specific estimates from a prospective study. BMJ. 2000;321(7271):1259–62.

4. Wilcox AJ, Dunson DB, Weinberg CR, Trussell J, Baird DD.

Likelihood of conception with a single act of intercourse:

providing benchmark rates for assessment of post-coital contraceptives. Contraception. 2001;63(4):211–5.

5. Tepper NK, Steenland MW, Marchbanks PA, Curtis KM.

Laboratory screening prior to initiating contraception:

a systematic review. Contraception. 2013;87(5):645–9.

6. Tepper NK, Steenland MW, Marchbanks PA, Curtis KM et al. Hemoglobin measurement prior to initiating copper intrauterine devices: a systematic review. Contraception.

2013;87(5):639–44. doi:10.1016/j.contraception.2012.08.008.

7. Grimes DA, Schulz KF. Prophylactic antibiotics for intrauterine device insertion: a metaanalysis of the randomized controlled trials. Contraception. 1999;60(2):57–63.

8. Godfrey EM, Whiteman MK, Curtis KM. Treatment of bleeding irregularities in women with copper-containing IUDs: a systematic review. Contraception. 2013;87(5):549–66.

doi:10.1016/j.contraception.2012.08.005.

9. Tepper NK, Steenland MW, Gaffield ME, Marchbanks PA, Curtis KM. Retention of intrauterine devices in women who acquire pelvic inflammatory disease: a systematic review. Contraception. 2013;87(5):655–60. doi:10.1016/j.

contraception.2012.08.011.

10. Brahmi D, Steenland MW, Renner RM, Gaffield ME, Curtis KM. Pregnancy outcomes with an IUD in situ: a systematic review. Contraception. 2012;85(2):131–9. doi:10.1016/j.

contraception.2011.06.010.

11. Steenland MW, Lauren B, Zapata LB, Brahmi D, Marchbanks PA, Curtis KM. The effect of follow-up visits or contacts after contraceptive initiation on method continuation and correct use. Contraception. 2013;87(5):625–30.

doi:10.1016/j.contraception.2012.09.018.

7.3 Progestogen-only